Zimmer Biomet Recalls Z Nail Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 1,707 sterile Z Nail implants because packaging design verification tests failed. The action covers domestic and foreign distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites packaging design verification test failures but does not report any illnesses, injuries, or specific hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for 1,707 sterile-packaged Z Nail implants. The affected products include various models of Z Nail PF, Z Nail GT, and Z Nail Tibia implants, specifically the 14mm x 46cm, 14mm x 38cm, 14mm x 40cm, 14mm x 42cm, and 14mm x 44cm configurations.
The recall is being conducted due to packaging design verification test failures. The source text does not specify the nature of the failures or any reported adverse health events, injuries, or illnesses associated with the use of these devices.
The affected units were distributed domestically to numerous US states and territories, as well as to various foreign countries including Canada, Australia, and several nations in Europe, Asia, and the Americas. Consumers and healthcare providers should check their inventory against the specific lot numbers and item numbers listed in the official recall documentation to determine if they possess affected units.
The recalled product
- Product
- Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,707
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 510K:K083497
Distribution
Part of a larger recall action
This product is one of 8 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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